Pulmonary ThromboembolismNCT01580085
Obstructive Sleep Apnea in Pulmonary Embolism
An observational study of Pulmonary Thromboembolism and Obstructive Sleep Apnea, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Thromboembolism, Obstructive Sleep Apnea
- What is being tested?
- polysomnography
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects admitted to Department of Pulmonary Medicine of Gaziantep University who were diagnosed to have PE were included in the study group. Control group consisted of age and sex matched subjects without a clinic consistent with PE referred to the Sleep Clinic. PE was diagnosed when one or more of the following was present: compatible physical examination findings and multislice CT angiography or presence of deep venous thrombus (DVT) in addition to high risk with Wells criteria [5]. Subjects with any restrictive/obstructive lung pathology or younger than 18 years old were excluded.
Who may be able to join
- All consecutive patients diagnosed with pulmonary embolism
Who cannot join
- less than 18 years of age
- any restrictive or obstructive lung disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Gaziantep Hospital
Gaziantep, 27310
About this study
Official title: Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. An increased tendency for coagulation has also been reported in OSA. Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.
- Conditions
- Pulmonary Thromboembolism, Obstructive Sleep Apnea
- Being tested
- polysomnography
- Keywords
- Sleep disordered breathing, gender, hypercoagulability
- Medical subject headings
- Pulmonary Embolism, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Coitus, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyOther
Also called PSG
full night supervised laboratory polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary embolism | Patients who were diagnosed with pulmonary embolism Receives: Other: polysomnography | |
| control group | age and sex matched adults with osa and no thromboembolism Receives: Other: polysomnography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, meral uyar, University of Gaziantep
- Investigators
- Meral Uyar, Assist Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580085
- Sponsor's protocol ID
- gantep gogus 1
- Status last verified
- Apr 2012
- First submitted
- 16 Apr 2012
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01580085
- Acronym / sponsor ID
- gantep gogus 1
- Conditions
- Pulmonary Thromboembolism, Obstructive Sleep Apnea
- Keywords
- Sleep disordered breathing, gender, hypercoagulability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. An increased tendency for coagulation has also been reported in OSA. Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary embolism | – | Other: polysomnographyPatients who were diagnosed with pulmonary embolism |
| control group | – | Other: polysomnographyage and sex matched adults with osa and no thromboembolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects admitted to Department of Pulmonary Medicine of Gaziantep University who were diagnosed to have PE were included in the study group. Control group consisted of age and sex matched subjects without a clinic consistent with PE referred to the Sleep Clinic. PE was diagnosed when one or more of the following was present: compatible physical examination findings and multislice CT angiography or presence of deep venous thrombus (DVT) in addition to high risk with Wells criteria [5]. Subjects with any restrictive/obstructive lung pathology or younger than 18 years old were excluded.
Key inclusion criteria (1 listed)
- All consecutive patients diagnosed with pulmonary embolism
Key exclusion criteria (2 listed)
- less than 18 years of age
- any restrictive or obstructive lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnographyAlso: PSGfull night supervised laboratory polysomnography | Other | Pulmonary embolism, control group |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Uyar, Assist Prof principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Thromboembolism and Obstructive Sleep Apnea, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2012.